Prismaflex Addendum to Operators Manual Sw Ver 7.xx May 2015

Stand without drip tray

Figure 1-2. Stand - front view 1. Brake lever Push the lever to lock the casters. Lift the lever to unlock the casters. Chapter 13 Specifications Weight, height, width and base specification shall be replaced with below information: Stand without drip tray

Stand with drip tray

Weight

Approximately 78 kg (172 lb) without fluid bags and Prismaflex disposable set

Height

Approx. 163 cm Approx. 163 cm (64 in) (64 in)

Width

Approximately 49 cm (19 in)

Base

Approximately 60 cm × 63 cm (24 in × 25 in)

2

Approximately 70 cm × 70 cm (28 in × 28 in)

HCEN12719 Revision 05.2015

Prismaflex® Operator's Manual For use with software versions 7.xx

Manufacturer: Gambro Lundia AB Box 10101, Magistratsvägen 16, SE-220 10 Lund, Sweden Tel: +46-46-16 90 00, Fax: +46-46-16 96 96 www.gambro.com Questions or comments about this publication can be directed to your local representative or to the manufacturer.

Order number: G503991

Copyright: © 2005–201 GDmbro/undia$B Gambro, Prismaflex, Prismaflo, Prismacomfort, Prismatherm, MARSFLUX, diaFLUX, diaMARS, X-MARS, Hospal and MARS are trademarks belonging to the Gambro Group.

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Prismaflex® 1. Before You Get Started 2. Description of the Prismaflex® System 3. General Prismaflex® Functions 4. Operating the Prismaflex® System 5. Continuous Renal Replacement Therapies (CRRT) 6. Therapeutic Plasma Exchange (TPE) 7. Anticoagulation Methods 8. Blood Warmers 9. Alarm System 10. Troubleshooting 11. Maintenance 12. Specifications 13. Prismaflex® Disposable Sets 14. User-controllable Settings 15. Index

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Chapter 1 Before You Get Started Contents

General Information... 1:2 Intended Use... 1:2 Contraindications... 1:2 Keywords Used in this Manual... 1:2 Where to Find Information... 1:3 Operator’s Manual... 1:3 Online Instructions... 1:3 Instructions for Use of Prismaflex® Disposable Sets... 1:3 Therapies... 1:4 Anticoagulation Methods... 1:4 Responsibility and Disclaimer... 1:5 Safety Definitions... 1:5 General Warnings and Cautions... 1:6 Warnings... 1:6 Cautions... 1:9 Symbols... 1:11 Electrical Safety... 1:11 Instructions and Warnings... 1:12 Information... 1:12 Communication... 1:13 Environmental... 1:13 Transportation and Storage... 1:13 Solutions... 1:14 Certification Marks... 1:14 Installation, Service and Transport... 1:15 Disposal... 1:15 Disposal of Packaging Material... 1:15 Disposal of Discarded Equipment... 1:15 Hazardous Substances... 1:16 Disposal of Waste Batteries and Accumulators... 1:16

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General Information Intended Use The Prismaflex control unit is intended for: •

Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.

•

Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.

•

Continuous Renal Replacement Therapy (CRRT) in conjunction with the MARS system to conduct MARS treatments for patients weighing 20 kilograms or more.

All treatments administered via the Prismaflex control unit must be prescribed by a physician.

Contraindications For contraindications that may apply to the disposable set selected for the therapy, refer to the Instructions For Use of the disposable set.

Keywords Used in this Manual Authorized service technicians This term refers to Gambro trained and certified service technicians. Filter Depending on the therapy in use, Filter stands for either: •

Hemofilter/Dialyzer

•

Plasmafilter

Manual The term Manual refers to this Operator's Manual unless specified differently. Operator In this manual, Operator designates appropriately trained and qualified clinical staff who is in charge of the Prismaflex control unit. The operator sets the prescribed values in accordance with the prescribed treatment, responds to alarms, troubleshoots the Prismaflex control unit, handles the bags, etc. Once the training material is read through and understood, the operator is approved to operate the Prismaflex control unit. The operator works within one meter from the front of the Prismaflex control unit. Responsible Organization In this manual, Responsible Organization means a function or a person who can identify, analyze, and control potential risks that could occur, for example, when connecting the Prismaflex control unit to other equipment or when making changes to the equipment connected to the Prismaflex control unit.

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Screens The Prismaflex control unit displays different screens during operation. Whenever a screen is referred to in this manual, it is identified by its title, e.g. Enter Flow Settings screen or Status screen. Softkeys Whenever a Softkey on the Prismaflex screen is referred to in this manual, it is written in capital italic letters, e.g. NEW PATIENT or CHANGE BAG. Training Material This operator's manual is the primary training material for staff who is to operate the Prismaflex system.

Where to Find Information Operator’s Manual This manual provides operating, maintenance, and troubleshooting instructions, as well as general information. Chapter 2: “Description of the Prismaflex® System” provides information about the Prismaflex control unit and system components. Chapter 3: “General Prismaflex® Functions” describes the principles of operation of the system, notably about fluid and pressure management. Chapter 4: “Operating the Prismaflex® System” explains the system interface, gives an overview of a treatment sequence and describes the routine handling steps. Specific therapy information is provided for: •

CRRT in chapter 5: “Continuous Renal Replacement Therapies (CRRT)”

•

TPE in chapter 6: “Therapeutic Plasma Exchange (TPE)”

•

Anticoagulation in chapter 7: “Anticoagulation Methods”

Online Instructions Detailed operating instructions are incorporated in the software of the Prismaflex control unit. The instructions are available online, through the interactive display. Instructions include the following screens: •

Operating screens (step-by-step instructions that the operator follows each time in setting up, administering treatment, verifying settings, and ending patient treatments).

•

Alarm screens (instructions when an alarm situation occurs).

•

Help screens (additional information about an operating or alarm screen).

Instructions for Use of Prismaflex® Disposable Sets Instructions for use are provided with Prismaflex disposable sets, and provide operating flow rates, filter pressures, priming requirements, performance data, and other information for use of the set with the Prismaflex system.

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Therapies The Prismaflex control unit pumps blood from the patient, through the filter in a Prismaflex disposable set, and back to the patient’s venous circulation. As the blood passes through the filter, the desired treatment processes take place. Depending on the therapy in use, these processes can include fluid removal and/or solute clearance. For instructions about the different therapies, see each respective therapy chapter. During the setup procedure, the operator selects the therapy desired. The Prismaflex system provides: CRRT – Continuous Renal Replacement Therapies •

SCUF – Slow Continuous Ultrafiltration

•

CVVH – Continuous Veno-venous Hemofiltration

•

CVVHD – Continuous Veno-venous Hemodialysis

•

CVVHDF – Continuous Veno-venous Hemodiafiltration

CRRT MARS®– Continuous Renal Replacement Therapies supporting Molecular Adsorbents Recirculation System •

CVVHD – Continuous Veno-venous Hemodialysis

•

CVVHDF – Continuous Veno-venous Hemodiafiltration

TPE – Therapeutic Plasma Exchange

Note: All therapies beside CRRT require a service configuration. Contact your local representative for additional information. Note: Check your local regulations for any restrictions on therapies, disposables, solutions, etc.

Anticoagulation Methods For detailed instructions about the different anticoagulation methods, see chapter 7: “Anticoagulation Methods.” During the setup procedure, the operator selects the desired anticoagulation method. The Prismaflex system includes: •

Systemic, Prismaflex syringe pump

•

No anticoagulation

Note: All anticoagulation methods beside “No anticoagulation” require a service configuration. Contact your local representative for additional information.

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Responsibility and Disclaimer Gambro accepts responsibility for the safety, reliability, and performance of this equipment only: •

If any modifications to the equipment have been authorized in writing by Gambro and carried out by an authorized service technician.

•

If the electrical installation for powering the equipment complies with all applicable local electrical codes and requirements including, if applicable, IEC requirements.

•

If the equipment is used in accordance with this manual.

Gambro will provide, on request, a service manual which contains all necessary circuit diagrams, calibration instructions, and service information to enable authorized service technicians to repair those parts of this equipment which Gambro considers to be repairable. This manual contains references to accessories and disposables for use with the Prismaflex system, see chapter 2: “Description of the Prismaflex® System” on page 2:1. The Prismaflex system has been tested and validated for use with these accessories and disposables. Gambro does not accept any responsibility or liability for use of accessories or disposables other than those specified in this manual or if any specified accessory or disposable is not used in accordance with this manual, online instructions and the Instructions for Use accompanying those accessories and disposables. Since Gambro has no control over service work which is not performed by authorized service technicians, Gambro will in no way be responsible or liable for any damages resulting from the operation or performance of any device, or any injury caused thereby, after repair has been performed by any person other than an authorized service technician of Gambro. Under no circumstances will Gambro be liable for any indirect, incidental, special or consequential damages of any kind, its liability being hereby limited solely to repair or replacement. Note: Check your local regulations for any restrictions on therapies, disposables, solutions, etc. that may apply.

Safety Definitions This manual uses the following safety definitions: WARNING A warning alerts the reader about a situation which, if not avoided, could result in an adverse reaction, injury or death. WARNING CAUTION A caution alerts the reader about a situation which, if not avoided, could result in minor or moderate injury to the user or patient or damage to the equipment or other property. CAUTION

Note: Notes are added to give more information.

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General Warnings and Cautions Warnings WARNING General Carefully read this Prismaflex Operator’s Manual and the Prismaflex disposable set and solution bag Instructions for Use before operating this device. Note: Deviation in the classification of a warning and a caution between the manual and disposable IFU may occur. If found, refer to the manual. Before first use, ensure that the installation test has been successfully performed. Operate the Prismaflex control unit in accordance with this manual, the Instructions for Use of the Prismaflex disposable set and solutions, and the online instructions. The use of operating or maintenance procedures other than those published by the manufacturer, or the use of accessory devices not recommended by the manufacturer, can result in patient injury or death. The manufacturer will not be responsible for patient safety if the procedures to operate, maintain, and calibrate the Prismaflex system are other than those specified in this manual, the Service Manual, the Instructions for Use of the Prismaflex disposable set and solutions, and the online instructions. Procedures using the Prismaflex system must be performed under the responsibility of a physician. Procedures using the Prismaflex system must be performed by trained and qualified clinical staff. Service and Repairs Service and repairs are only allowed to be performed by an authorized service technician. Ensure that scales and pressure sensors of the Prismaflex control unit are accurately calibrated. Calibrations must be performed by an authorized service technician. Electrical Safety All electrical installations must comply with all applicable local electrical codes and the manufacturer’s specifications. The correct installation of a medical electrical system requires that each system component be individually connected to the main power. It is strongly recommended not to use multiple portable socket-outlets. However, if using multiple portable socket-outlets, they must comply with IEC 60601-1-1 and must not be placed on the floor. Additional multiple portable socket-outlets must not be connected to the system. Use only the Prismaflex hospital grade power cord to connect the Prismaflex control unit to the facility’s electrical outlet. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective ground. Environment Do not use the Prismaflex control unit near flammable gas or a flammable anesthetic mixture with air, oxygen, or nitrous oxide. WARNING → → → 1:6

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→ → → WARNING Do not use cellular phones or other radiofrequency emitting equipment within a short distance from the Prismaflex control unit since disturbance may occur. Refer to “Guidance and Manufacturer’s Declaration - Electromagnetic Emissions and Immunity” on page 12:11 in this manual. Patient Data Management Systems and Remote Alarms If a Patient Data Management System (PDMS) is to be used with the Prismaflex system, the Responsible Organization is obliged to verify compatibility between the two systems. The use of a PDMS not compatible with the Prismaflex system can result in presentation of erroneous data. It is the responsibility of the physician to verify all data before prescribing any therapeutic or pharmacological action for the patient. If a remote alarm is to be used with the Prismaflex system, the Responsible Organization is obliged to verify its function. Even if a remote alarm is used, the operator is obliged to periodically monitor the patient in person. Handling the Prismaflex Control Unit Lock brakes on the wheels to limit movement of the control unit that might pull on tubing connected to the patient or significantly alter fluid balance. After turning ON the Prismaflex control unit, verify the audible alarm and that the green, yellow, and red status lights are lit alternately during the Prismaflex startup sequence. In case of malfunction, switch OFF the Prismaflex control unit and call for service. Never insert fingers in the return line clamp or in the pinch valves. Setup and Priming During priming and operation, observe the system closely for leakage at joints and connections within the set. Leakage can cause blood loss or air embolism. If leakage cannot be stopped by tightening the connections, replace the set. Clamp unused lines after priming is complete and before starting a patient treatment according to therapy configuration. Before connecting the blood return line to the patient, make sure the blood line segment from the air bubble detector to the patient is free of air. Install the discharger ring on the Prismaflex disposable set in its guide before connecting a patient to the Prismaflex system in order to minimize cardiac monitor disturbance. Misinterpretation of ECG readings due to artefacts may lead to patient injury or death. Treatment Monitoring Carefully observe the Prismaflex treatment system, including the disposable set, during a patient treatment. Monitor patient blood chemistry to ensure electrolyte balance and normoglycemia. Monitor patient temperature to avoid hypo- or hyperthermia. Pay special attention when using high fluid exchange rates, when using a high capacity blood warmer, or when treating low body weight patients. WARNING → → →

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→ → → WARNING Blood or fluid leakage from a pod diaphragm or wetting of the fluid barrier at the distal end of the monitor line will impair pressure monitoring in the Prismaflex system and requires immediate troubleshooting. Follow the instructions in section “Leakage in Pressure Pods or Blood Reaching Fluid Barrier” on page 10:61. Always connect the return line directly to the blood access device. Do not connect additional devices between the return line and the blood access device. The use of additional devices, such as three-way valves, stopcocks, or extension lines, may impair return pressure monitoring. Their use can impede the detection of return disconnections, potentially resulting in severe blood loss. The Prismaflex control unit may not be able to detect disconnections of the set from the blood access device, which can result in severe blood loss. Ensure that the patient's blood access and return connections are firmly secured; pay special attention in case a warmer sleeve is in use. The Prismaflex control unit may not be able to detect all situations that can result in hemolysis, including kinks in a blood line or cannula that are too thin. Observe the effluent bag for pink or red tinge as an indicator of hemolysis. Air may enter into the extracorporeal circuit at connection points downstream of the air detector if pressures are negative. Ensure that the patient's blood return connection is firmly secured. Do not connect additional devices between the return line and the blood access device. Collecting blood samples from improper sample sites in the set can lead to incorrect blood chemistry results. The dilution effect of infusions must be considered according to the flow settings and sample sites, for example PBP infusion rate on an access site blood sample. After pumps have (re)started, wait for some minutes before taking a blood sample to obtain stabilized conditions. Always inspect the blood flowpath for signs of clotting before returning the blood in the disposable set to the patient. If clotting is suspected, do not return the blood to the patient. Fluid Management The Prismaflex control unit is intended to be used on patients weighing 20 kg or more. A higher minimum patient weight limit may apply for the disposable set selected for the therapy. Refer to the Instructions For Use of the disposable set and Table “Sets and patient weight limits” on page 2:17. Fluid balance deviations, even if within the specified Prismaflex control unit accuracy, can exceed a level that can be tolerated by low-weight patients. The overall patient fluid balance is subject to fluid losses or gains outside the control of the Prismaflex treatment system. The overall fluid balance must therefore be periodically verified by weighing the patient. Ignoring and/or indiscriminately pressing the CONTINUE softkey as a response to Caution: Flow Problem alarms may lead to incorrect patient weight loss or gain. Always identify and solve the originating cause of alarms before pressing the CONTINUE softkey. Do not hang anything except fluid bags on the scales of the Prismaflex control unit. Foreign objects on the scales can significantly alter fluid balance. Leakages from the fluid bags can significantly alter fluid balance. Carefully observe fluid bags and connectors during treatment. WARNING → → → 1:8

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→ → → WARNING Solutions and Bags Ensure that dialysate solution and infusion solutions (PBP and replacement) are of appropriate composition and at appropriate temperature, as prescribed by a physician. Before using a solution/fluid, make sure it is free of precipitates and other particulate matter. The use of incorrect solution/fluid can result in patient injury or death. The Prismaflex system is unable to detect all situations in which a fluid bag has been attached to the wrong line or has been hung on an incorrect scale. It is the sole responsibility of the operator to verify that bags are properly connected and hung on the correct scale, as indicated by the Prismaflex graphical user interface. When connecting solution bags, follow the instructions in the package insert of the solution for correct use of the access ports. Incorrect use of the access port or other restrictions to fluid flow might lead to incorrect patient weight loss and may result in machine alarms. Continuing treatment without resolving the originating cause may result in patient injury or death. When hanging a fluid bag, evenly distribute its weight among the three hooks of the scale carrying bar. If only one hook is needed, use the center hook. Failure to comply can significantly alter fluid balance. Hygienic Considerations Use aseptic technique when handling the blood and fluid lines in the disposable set. Do not use the Prismaflex disposable set if the package is damaged, if the sterilization caps are missing or loose, or if the blood lines are kinked. Destroy the Prismaflex disposable set after a single use, using appropriate procedures for potentially contaminated material. Do not resterilize. Do not use the Prismaflex control unit after blood leakage from a pod diaphragm or after blood having passed the fluid barrier at the distal end of the monitor line. Place the control unit into quarantine to avoid risk of infection and have it inspected by an authorized service technician. Use a 21-gauge (or smaller) needle to obtain blood or fluid samples. Use of larger needles can cause leaks in the sample sites, resulting in blood loss or air embolism. Use aseptic technique whenever inserting needles into sample sites. WARNING

Cautions CAUTION

General Federal law (USA) restricts this device to sale by or on the order of a physician. Service and Repairs Do not open the Prismaflex control unit. There are no operator-serviceable parts inside the device. Only authorized service technicians may access Service mode. If Service mode is inadvertently entered, restart the control unit to return to Operating mode. CAUTION → → →

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→ → → CAUTION Electrical Safety Although all Prismaflex systems comply with IEC 60601-1 requirements for hemodialysis machines (Type BF applied part), it is recommended that a Prismaflex control unit Type CF applied part is used when the blood access is from a central dialysis catheter. The type label at the back of the control unit indicates the classification. Note: The combined Prismaflex and MARS system complies with the Type B applied part classification per IEC 60601-1 standard. Devices connected to the RS232 serial communication port or the Ethernet port must comply with IEC 60950. Connected cables must have a Kitagawa RFC-10 ferrite or equivalent to fulfill EMC requirements. Environment Refer to the Prismaflex disposable set Instructions for Use and the solution/fluid package insert for environmental requirements, including storage conditions. Variations in room temperature of ±3 °C (5.4 °F) or more can cause the scales to become inaccurate. Handling the Prismaflex Control Unit Before moving the Prismaflex control unit, check that the brake is released and ensure that all of the scales are firmly closed. Setup and Priming Pay particular attention to the extracorporeal blood volume. For patients with a high ratio of extracorporeal volume to patient blood volume, the physician may decide to prime the extracorporeal circuit with adequate volume substitution before patient connection. Do not allow air to enter the blood compartment of the disposable set after priming has started. If a large amount of air enters, the set must be replaced. If a patient is not connected to the Prismaflex disposable set shortly after priming is complete, flush the set with at least 500 ml priming solution (saline with heparin added) before connecting a patient. This may require the use of a new bag of priming solution and a new (empty) collection bag. Consult the Instructions for Use packaged with the set for details about priming volumes. Treatment Monitoring Pay careful attention to the possible medical hazards associated with coagulation in the blood flowpath. Blood return from a blood primed extracorporeal circuit can result in hypervolemia. Consult physician's prescription. Hygienic Considerations To prevent contamination, the Prismaflex disposable set must be used as soon as its package and sterilization caps are removed. Chemicals other than those recommended in this manual for cleaning and disinfection could damage the Prismaflex control unit and Prismaflex disposable sets. Obtain permission from the manufacturer before using a non-recommended chemical on the Prismaflex system. Do not use halogenated aromatic and aliphatic solvents or ketonic solvents. CAUTION

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Symbols If applicable, the following symbols appear on or near the serial number label or other permanently affixed labels of this device. For more information, see chapter 12: “Specifications” on page 12:1.

Electrical Safety Equipment applied part is Type BF, defibrillation - proof per IEC 60601-1. Note: To be sure of the Prismaflex control unit’s classification see type label found at the back of the Prismaflex control unit. Equipment applied part is Type CF, defibrillation-proof per IEC 60601-1. Note: To be sure of the Prismaflex control unit’s classification see type label found at the back of the Prismaflex control unit. Device meets the “drip proof” classification requirements.

Device requires an alternating supply current. Nearby high-voltage conductors could be hazardous if contacted.

This symbol is located near functional ground locations on this device.

This symbol is located near protective ground locations on this device.

This symbol identifies the point of connection of a potential equalization conductor. The terminal is connected to the chassis and should be connected to corresponding terminals on other equipment in order to eliminate potential differences.

Fuse. Certain components within this equipment are sensitive to electrostatic discharge.

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Instructions and Warnings Attention, consult accompanying documents.

Read instructions before use.

This symbol warns against an incline of the Prismaflex control unit of more than 5° from the floor. Note: This warning label must be applied on the warmer holder before use. It should be mounted on deliverance. The background color is yellow. Pull out scale completely before hanging bag.

Pull out scale completely before hanging bag.

Risk of tipping the Prismaflex control unit from pushing, leaning, resting, etc. The colors are red, white, and black.

7kg

This symbol is applied on the stand if the Prismaflex calibration weight kit is stored inside. Calibration weights are to be removed before tilting the Prismaflex control unit into horizontal position. The color is black on a yellow background.

Information Date of manufacture with year as four digits.

Manufacturer. The year of manufacture may be included in the symbol expressed as four digits.

Catalog number.

Serial number.

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Communication Ethernet port.

RS232 Serial Communication port. Remote alarm connection.

Environmental This symbol indicates that: – since the equipment contains dangerous substances, it must be recycled rather than disposed together with other municipal waste; – the equipment was placed on the market after 13 August 2005. The device contains toxic or hazardous substances or elements.

25 Recycle the cardboard.

CB

Transportation and Storage Fragile – handle with care.

Keep dry.

100 kg max

The maximum stacking load permitted on the transport package is 100 kg.

This end up.

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Atmospheric pressure limitation. Upper and lower limits are expressed with numeric values in kPa.

Humidity limitation. Upper and lower limits are expressed with numeric values in %.

Temperature limitation. Upper and lower limits are expressed with numeric values in degrees Celsius or Fahrenheit.

Solutions Circle sign; placed as colored symbol on effluent scale and in the graphical user interface in screens related to effluent. On the disposable set the symbol is a relief shape in the plastic cover indicating the effluent pump. Triangle sign; placed as colored symbol on PBP scale and in the graphical user interface in screens related to PBP. On the disposable set the symbol is a relief shape in the plastic cover indicating the PBP pump. Square sign; placed as colored symbol on dialysate scale and in the graphical user interface in screens related to dialysate. On the disposable set the symbol is a relief shape in the plastic cover indicating the dialysate pump. Octagon sign; placed as colored symbol on replacement scale and in the graphical user interface in screens related to replacement. On the disposable set the symbol is a relief shape in the plastic cover indicating the replacement pump.

Certification Marks The CE-conformity mark indicates that the Prismaflex control unit conforms to the requirements in the EC Council Directive 93/42/EEC of 14 June, 1993 concerning medical devices. It also indicates that the notified body British Standards Institution (BSI, No. 0086) has approved the Quality Management System. The CE conformity mark is only valid for the Prismaflex control unit. Disposables and any accessories specified for use with the Prismaflex control unit are marked with CE conformity marks in their own right. (See “ Prismaflex® Disposable Sets” on page 2:16.) The CSA (C-US) mark indicates that the Prismaflex control unit conforms to the requirements related to safety of medical devices for the US and Canada. The “C” and the “US” adjacent to the CSA mark indicate that the Prismaflex control unit has been evaluated to the applicable ANSI/UL and CSA standards for use in the US and Canada. The CCC mark indicates that the Prismaflex control unit conforms to the safety requirements for China Compulsory Certification (CCC) as described by the competent authority Certification and Accreditation Administration of People's Republic of China (CNCA). The “S” adjacent to the CCC mark indicates that safety requirements are met.

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